The invention can be used advantageously to suture vessels, ducts, and the like, in a patient body. The invention can be used particularly advantageously in suturing blood vessels together during cardiac surgery, for example. Accordingly, the invention can be used during coronary artery bypass graft surgery (CABG), and the like. However, it is to be appreciated that the field of the invention is not to be limited to such uses only, but extends to suturing patient tissue together in general. For example, the invention can be used also to form sutures in bowel connections, femoral-popliteal artery anastomoses, and the like. It can also be used in the field of trauma closure, and the like.
It is often required to connect a vessel, duct, or the like, such as a hollow organ, or blood vessel, or the like, to a target piece of tissue, such as another vessel, duct, or the like. This is especially true in the case of certain types of cardiac surgery, such as CABG surgery. Often during such CABG surgery it is required to connect, or join, one blood vessel to another so that the vessels are joined together to be in fluid flow communication with each other. A joint formed between blood vessels in this fashion is often referred to as an anastomosis.
As is well known, the heart pumps blood through the body. The heart comprises a plurality of muscles which cooperate with one another to cause contractions of the heart thereby to provide a pumping action. The heart requires blood flow to its muscles to provide its muscles with the necessary oxygen, nutrients, and the like, necessary for muscular contraction. It often happens that one or more of the blood vessels which feed the heart muscles becomes diseased and develops a blockage, or becomes occluded, or the like. When this happens, a region of the heart normally fed by that diseased blood vessel can experience a depletion, or interruption, of blood supply. If such a condition is not treated in a timely fashion, the patient may suffer a heart attack with often fatal results.
CABG procedures are often performed to circumvent such a blockage, or occlusion, in a diseased blood vessel, thereby to provide the region of the heart normally fed by the diseased vessel with blood. This procedure normally involves tapping blood from an appropriate blood source, such as a donor blood vessel such as, for example, the aorta, saphenous vein, mammary artery, or the like, and routing the tapped blood to the diseased vessel downstream of the occlusion or blockage. A variety of procedures are currently employed to provide tapped blood downstream of an occlusion, or blockage, in a diseased blood vessel. One procedure involves making use of a graft. In such a case, an end of the graft is typically sutured to an appropriate blood source to be in fluid flow communication therewith and an opposed end of the graft is typically sutured to a side of the diseased vessel to be in fluid flow communication therewith downstream of the occlusion, or blockage. Another procedure involves suturing a side of a healthy vessel to a side of a diseased vessel downstream of the blockage, or occlusion, so that blood can flow from the healthy vessel to the diseased vessel. A joint between an end of a vessel, or graft, and a side of another vessel, or graft, is often referred to as an end-to-side anastomosis. A joint between a side of a graft, or vessel, and a side of another graft, or vessel, is often referred to as a side-to-side anastomosis.
During CABG surgery, a patient is often connected to a cardiopulmonary bypass machine so that the heart can be stopped temporarily, thereby to ease the task of suturing the various grafts, and/or vessels, together. Furthermore, blood vessels, such as the aorta, for example, are often closed, or clamped, so as to interrupt blood flow through that vessel when that vessel is to be used as a donor vessel or blood source.
When CABG procedures are performed on a patient, the patient normally suffers a great deal of trauma. Accordingly, it would be beneficial if such CABG procedures could be improved so as to decrease patient trauma. In conventional CABG surgery, there are at least three factors that affect the degree of trauma suffered by a patient. These factors include: (1) the time the patient spends on a cardiopulmonary bypass machine, (2) the time the patient spends with a clamped blood vessel, such as the aorta, or the like, and (3) the quality of the anastomoses formed between the blood vessels and/or grafts. It is generally recognized that the risk of patient morbidity rises significantly after the patient has been placed on a cardiopulmonary bypass machine for a period of about one hour. Passage of blood through a cardiopulmonary bypass machine tends to damage blood cells consequently causing degradation in blood quality. Accordingly, the longer a patient is subjected to cardiopulmonary bypass, the more the blood cells become damaged and the higher the degradation in the quality of the blood. A complication often associated with prolonged placement on a cardiopulmonary bypass machine, is distal thrombosis. Distal thrombosis can give rise to embolization in the neurovasculature and can lead to the patient suffering a stroke. Accordingly, it would be beneficial if the period a patient spends on a cardiopulmonary bypass machine during CABG surgery could be reduced.
A factor by which the amount of time a patient spends on a cardiopulmonary bypass machine can be reduced is by reducing the time taken suturing the vessels and/or grafts together to form anastomoses. The average time taken to suture two vessels together to form an anastomosis in accordance with traditional suturing methods, is typically about seven to ten minutes. An average CABG procedure can involve the formation of about five anastomoses. Accordingly, the time spent on suturing during an average CABG procedure can be between about thirty-five to fifty minutes. Therefore, since the task of suturing can constitute a major portion of the one hour period, it would be advantageous if the time spent on such suturing could be reduced. By doing so, the time a patient is subjected to cardiopulmonary bypass would also be reduced, thereby reducing patient trauma and the risks of morbidity.
In so-called xe2x80x9coff-pumpxe2x80x9d procedures, patients are not placed on cardiopulmonary bypass machines. Accordingly, the negative effects associated with cardiopulmonary bypass mentioned above are inhibited. However, the task of suturing is made more difficult since the task of suturing is normally then performed while the heart is beating. This can lead to the formation of anastomoses with reduced integrity. Improperly suturing blood vessels and/or grafts together may lead to post operative complications. Incorrect suturing during surgery requiring correction during the surgery, may unnecessarily extend the time taken to complete the surgery.
Suture placement devices have been proposed which enable a surgeon, or the like, to place suture elements in patient tissue without manually holding and manipulating a suture needle, as has traditionally been the case. It has been found that the management of opposed ends of suture elements after having been placed in patient tissue with such a device can be rather tedious. This is especially true where the device is arranged to place a plurality of suture elements in patient tissue simultaneously. In such a case, opposed portions of each individual suture element are typically secured together to form a suture. It has been found that the opposed portions can become mixed up, or entangled, with one another, thereby unnecessarily complicating the suturing procedure and delaying its completion.
One such suture placement device is shown an described in U.S. patent application Ser. No. 09/784,704, filed Feb. 14, 2001 and entitled xe2x80x9cDevice and Method for Deploying and Organizing Sutures for Anastomotic and Other Attachments,xe2x80x9d the entirety of which is herein incorporated by reference.
Accordingly, it would be advantageous to provide systems, devices and methods for enabling suturing operations to be conducted with greater accuracy and in a shorter period of time. This is especially true if several vessels and/or grafts are to be sutured together during a CABG procedure.
According to one aspect of the invention, there is provided a suturing device including a suture guid and a needle holder. The suture guide includes a foot portion having an axis defined along a length of the foot portion. The foot portion includes a plurality of apertures, each aperture holding a suture. The needle holder movably holds at least one needle relative to a first side of the foot portion and movably holds at least one needle relative to a second side of the foot portion. The needles are movable into respective apertures, and the at least one needle on the first side of the foot portion is at an angle relative to the at least one needle on the second side of the foot portion. In another aspect of the invention, the device includes a body having a driving mechanism. At least one needle holder is adapted to be received by the body. The needle holder includes a plurality of needles wherein the needles are operatively coupled to the driving mechanism. The device may further include a suture holder having a first end and a second end. The first end is adapted to slidably engage the needle holder, and the second end further includes a plurality of apertures adapted to receive a plurality of sutures. The driving mechanism drives the needles into the second end of the suture holder at an angle relative to an axis extending along the first and second end of the suture holder.